MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	466P306AU
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to medial and posterior tilt of the filter at the superior end; anterior tilt at the inferior end where it contacts the inferior vena cava (ivc) wall; perforation of the ivc by all struts up to 6 mm with two anterior struts perforating the ivc at 4 mm and 5 mm and contacts the bowel.One medal strut perforates the ivc wall 4 mm and resides within the soft tissues; one posterior strut perforates the ivc wall and contacts the lc vertebral body; and two lateral struts perforate the ivc wall both at 4 mm and reside within the soft tissues.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.Date of event: please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused medial and posterior tilt of the filter at the superior end; anterior tilt at the inferior end where it contacts the inferior vena cava (ivc) wall; perforation of the ivc by all struts up to 6 mm with two anterior struts perforating the ivc at 4 mm and 5 mm and contacts the bowel.One medal strut perforates the ivc wall 4 mm and resides within the soft tissues; one posterior strut perforates the ivc wall and contacts the lc vertebral body; and two lateral struts perforate the ivc wall both at 4 mm and reside within the soft tissues.The indication for the filter implant has not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Please note that this is the initial report for this product.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b5, b6, b7, d1, d4, d10, g2, g3, g6, h1, h2 and h4.Additional information is pending and will be submitted within 30 days of receipt.
Event or Problem Description
Additional information received per the medical records indicate that the patient has a history of chronic and recurrent deep vein thrombosis (dvt).The filter was implanted via the patient's right internal jugular vein.An inferior vena cava (ivc) venography was performed using digital subtraction technique.There were no clots present within the common iliac veins nor ivc.The ivc caliber was normal.The renal glands were patent bilaterally.The filter was deployed midway between the lowest renal vein and the iliac vein bifurcation.The filter appeared well seated and was aligned in a parallel fashion within in the lumen of the ivc.The patient tolerated the procedure well.Computed tomography (ct) scan done approximately eleven years and ten months after the index procedure was re-evaluated thirteen years and seven months after the index procedure.The results of this review were previously reported.Additional information received per the patient profile form (ppf) states that the patient experienced tilt, ivc perforation and organ perforation.The patient became aware of the reported events approximately thirteen years and seven months after the index procedure.The patient continues to worry about the filter failing.
Additional Manufacturer Narrative
It was reported that a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused medial and posterior tilt of the filter at the superior end; anterior tilt at the inferior end where it contacts the inferior vena cava (ivc) wall; perforation of the ivc by all struts up to 6 mm with two anterior struts perforating the ivc at 4 mm and 5 mm and contacts the bowel.One medal strut perforates the ivc wall 4 mm and resides within the soft tissues; one posterior strut perforates the ivc wall and contacts the lc vertebral body; and two lateral struts perforate the ivc wall both at 4 mm and reside within the soft tissues.The patient reported becoming aware of the events approximately thirteen years and seven months post implant, when the results of a computed tomography (ct) scan were reported.According to the medical record, the indication for the filter implant was chronic and recurrent deep vein thrombosis.The filter was placed via the right internal jugular vein and deployed midway between the lowest renal vein and the iliac vein bifurcation.Pre-deployment venography demonstrated no evidence of clots in the common iliac veins or the ivc.The ivc was noted to be of normal caliber.Post deployment the filter appeared well seated and was aligned in a parallel fashion within in the lumen of the ivc.The patient tolerated the procedure well.The product remains implanted and unavailable for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15324500
• Report Number: 9616099-2022-05932
• Device Sequence Number: 5518072
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0608222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 09/22/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/12/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 0.35 INQUIRE WIRE; UNKNOWN 6 FRENCH SHEATH - 60 CM; UNKNOWN CATHETER-22 GAUGE; UNKNOWN DILATOR
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female